MAUDE Adverse Event Report: MAKO SURGICAL CORP. 2.7 DEGREE STRAIGHT SAGITAL SAW; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 212186

Device Problems Difficult to Insert (1316); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

Saw attachment would not tighten the saw blade.Case type: tka surgical delay: 16-30 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Saw attachment would not tighten the saw blade.Case type: tka surgical delay: 16-30 minutes product inspection product was not inspected as the product was not returned for evaluation device history review product history review respectively shows the 50 devices were manufactured and 48 were accepted into final stock on 11-16-2017 with no reported discrepancies.Review of qt 17-11-0060 revealed that the non-conformance(s) is/are not related to the failure alleged in this complaint.Complaint history review a review of complaints in catsweb and trackwise related to p/n 212186, lot 35031017 shows 3 additional complaints related to the failure in this investigation.Conclusion the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

Event Description

Saw attachment would not tighten the saw blade.Case type: tka surgical delay: 16-30 minutes.

• Brand Name: 2.7 DEGREE STRAIGHT SAGITAL SAW
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8946679
• MDR Text Key: 156032315
• Report Number: 3005985723-2019-00617
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486032111
• UDI-Public: 00848486032111
• Combination Product (y/n): N
• PMA/PMN Number: K143752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 212186
• Device Lot Number: 3502422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization